RAPID framework for improved access to precision oncology for lethal disease: Results from a modified multi-round...

Area of Science:

• Oncology
• Clinical Trials
• Health Policy

Background:

• Predictive oncology, germline technologies, and adaptive seamless trials offer promising advances for lethal cancers.
• Access to these breakthrough therapies is significantly limited by high research costs, regulatory barriers, and systemic inequalities, exacerbated by the COVID-19 pandemic.

Purpose of the Study:

• To develop a comprehensive strategy for rapid and equitable patient access to novel cancer therapies.
• To identify and address systemic barriers hindering access to cutting-edge cancer treatments and clinical trials.

Main Methods:

• A modified multi-round Delphi study involving 70 experts across oncology, clinical trials, regulatory affairs, patient advocacy, ethics, drug development, and health policy in Canada, Europe, and the US.
• Semi-structured ethnographic interviews (n=33) were conducted to identify key issues and potential solutions.
• Survey data (n=47) and interview findings were co-analyzed, followed by an in-person roundtable (26 participants) to draft system-change recommendations.

Main Results:

• Experts highlighted significant patient access burdens related to time, cost, and transportation for trial eligibility and participation.
• Only 12% of respondents expressed satisfaction with current research systems.
• Top concerns identified were "patient access to trials" and "delays in study approval."

Conclusions:

• An equity-centered precision oncology communication model is essential for improving access to adaptive seamless trials and reforming eligibility criteria.
• Involving international advocacy groups is crucial for building patient trust and ensuring representation throughout research and therapy approval processes.
• Governments, researchers, and payors must collaborate in an ecosystem approach to facilitate faster, equitable access to life-saving cancer therapeutics, considering individual patient circumstances.